2024 RAC Medical Marketing Practice Exam With Answers (89 Solved Questions)
2024 RAC Medical Marketing Practice Exam With Answers is an essential tool for practicing past exams, giving you the opportunity to test your knowledge and improve your exam performance.
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RAC Practice Exam Latest Updated 2024 With Complete Solutions
You have modified your 510(k)-cleared device with a Special 510(k). In which case
would a Special 510(k) not be appropriate for the device? - You have changed the
primary mechanism of action.
Which Premarket Approval Application (PMA) supplements are NOT subject to user
fee exemption? - Real Time Supplement
A medical device company allows its sales force to maintain a product inventory in
the field. The device has an expiration date indicated on its labeling. A sales person
notes that one of his products has expired and contacts the headquarters office
for direction. He is told to return the product to the headquarter office for
replacement. The return of this product is considered as what type of recall? -
Not a recall—it is considered normal stock rotation
A company is developing an (unapproved) drug-device combination product but is
not sure to which center it should submit its marketing application. The company
should first submit - A Request for Designation to the Office of Combination
Products
A medical device company is developing a product with drug, biologic and device
components. The product and indication have not been previously classified by
FDA. What is the most appropriate regulatory pathway? - A Request for
Designation (RFD) should be sent to the Office of Combination Products (OCP) at
FDA to determine the primary mode of action (PMOA) and assign the agency with
primary jurisdiction.
You have modified your 510(k)-cleared device with a Special 510(k). In which case
would a Special 510(k) not be appropriate for the device? - You have changed the
primary mechanism of action.
Which Premarket Approval Application (PMA) supplements are NOT subject to user
fee exemption? - Real Time Supplement
A medical device company allows its sales force to maintain a product inventory in
the field. The device has an expiration date indicated on its labeling. A sales person
notes that one of his products has expired and contacts the headquarters office
for direction. He is told to return the product to the headquarter office for
replacement. The return of this product is considered as what type of recall? -
Not a recall—it is considered normal stock rotation
A company is developing an (unapproved) drug-device combination product but is
not sure to which center it should submit its marketing application. The company
should first submit - A Request for Designation to the Office of Combination
Products
A medical device company is developing a product with drug, biologic and device
components. The product and indication have not been previously classified by
FDA. What is the most appropriate regulatory pathway? - A Request for
Designation (RFD) should be sent to the Office of Combination Products (OCP) at
FDA to determine the primary mode of action (PMOA) and assign the agency with
primary jurisdiction.
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